BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1011699 · Received March 10, 2008

    Report

    Report Number
    1823260-2008-02269
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 10, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT SHE OBTAINED THE BLOOD GLUCOSE RESULTS OF 386 MG/DL AND 185 MG/DL WITHIN 10 MINUTES ON THE ACCU-CHEK COMPACT PLUS SYSTEM. NO ACTION WAS TAKEN BASED ON THE READINGS. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR LFR ROCHE DIAGNOSTICS 20672643

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK